# FDA recall Z-1313-2026

> **Medline Industries, LP** · Class II · device recall initiated 2025-12-24.

## Product

Intubation Tray (Adult) containing Suction Catheter Kits  SKU DYNJAA245B

## Reason for recall

A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.

## Distribution

Distribution US nationwide and Canada.

## Key facts

- **Recall number:** Z-1313-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-24
- **Report date:** 2026-02-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1313-2026

## Citation

> AI Analytics. FDA recall Z-1313-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1313-2026. Source: US FDA. Licensed CC0.

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